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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-012-000
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2016
Event Type  malfunction  
Event Description
It was reported that during a procedure, the tip of the device bent.No impact to the patient or procedural delays were reported with this event.
 
Manufacturer Narrative
Additional information: the reported event that the tip was bent was confirmed through the visual inspection.Any physical impact to the navigated instrument can cause product damage.
 
Event Description
It was reported that during a procedure, the tip of the device bent.No impact to the patient or procedural delays were reported with this event.
 
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Brand Name
SMALL POINTER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5802190
MDR Text Key49797905
Report Number0001811755-2016-01163
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6000-012-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received08/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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